UrolithiasisNCT04380675
Music During ESWL for Entire Treatment
A study testing Music in people with Urolithiasis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2017to 18 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing ESWL and interested in music listening
Who cannot join
- Contraindication to ESWL
- No interest in music listening
- Age < 18 and > 80
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (ESWL)
The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).
Read the detailed description
Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the ESWL treatment, patients in group B do not.
At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.
- Conditions
- Urolithiasis
- Being tested
- Music
- Keywords
- Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music
- Medical subject headings
- Urolithiasis, Kidney Calculi, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music listening during ESWL
| Study group | Role | What they receive |
|---|---|---|
| Music during ESWL | Active comparator | Patients listen to music during ESWL Receives: Other: Music |
| ESWL without music | No intervention | Patients don't listen to music during ESWL |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in VAS score
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
Measured: 10 mins after SWL treatment completed
Secondary outcomes (4)
change in Soundwave voltage (kV)
change in Soundwave voltage (kV)
Measured: 10 mins after SWL treatment completed
change in analgesic request
change in analgesic request
Measured: 10 mins after SWL treatment completed
change in requested interruptions
change in requested interruptions
Measured: 10 mins after SWL treatment completed
change in Soundwave number
change in Soundwave number
Measured: 10 mins after SWL treatment completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start2 Nov 2017
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Bosio, A.O.U. Città della Salute e della Scienza
- Investigators
- Andrea Bosio, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380675
- Sponsor's protocol ID
- AOUCSSTURAB002
- Status last verified
- May 2020
- First submitted
- 4 Dec 2015
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Listening to Decrease Pain and Discomfort During Extracorporeal Shock Wave Lithotripsy (ESWL)
- ClinicalTrials.gov ID
- NCT04380675
- Acronym / sponsor ID
- AOUCSSTURAB002
- Conditions
- Urolithiasis
- Keywords
- Urolithiasis, Kidney Calculi, Lithotripsy, Pain Management, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate if music listening relieves pain and discomfort during Extracorporeal Shock-Waves Lithotripsy (ESWL).
Detailed description
Patients undergoing ESWL and interested in music listening are randomly divided in two groups: patients in group A listen to music during the ESWL treatment, patients in group B do not.
At the end of the treatment patients are asked to fill in a questionnaire. They are asked if they were pleased to have had the opportunity to listen to music during ESWL, if they would like to listen to music again in case of further treatments, if they consider music helpful in relieving pain and discomfort during ESWL. Patients are also asked to mark their level of pain during each part of the treatment on a visual analogue scale (VAS) for pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music during ESWL | Active comparator | Other: MusicPatients listen to music during ESWL |
| ESWL without music | No intervention | –Patients don't listen to music during ESWL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing ESWL and interested in music listening
Key exclusion criteria (3 listed)
- Contraindication to ESWL
- No interest in music listening
- Age < 18 and > 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicMusic listening during ESWL | Other | Music during ESWL |
Primary outcome
change in VAS score
Time frame: 10 mins after SWL treatment completed
Visual analogue scale (VAS) - 0 to 10, higher values, worse pain
4 secondary outcomes
change in Soundwave voltage (kV)
Time frame: 10 mins after SWL treatment completed
change in analgesic request
Time frame: 10 mins after SWL treatment completed
change in requested interruptions
Time frame: 10 mins after SWL treatment completed
change in Soundwave number
Time frame: 10 mins after SWL treatment completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Bosio, MD principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Urolithiasis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in VAS score (time frame: 10 mins after SWL treatment completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.